Caffeine and Cataract After Pars Plana Vitrectomy

The Effect of Caffeine Consumption on Cataract Formation After Pars Plana Vitrectomy: a Comparative Study

Assessment of cataract development in patients with regular caffeine consumption and those without caffeine consumption after pars plana vitrectomy.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Procedure: Pars plana vitrectomy

Detailed Description

Vitrectomy is a frequently used surgical procedure in ophthalmology for various indications like retinal detachment repair or macular pucker peeling. Amongst others, accelerated cataract development in phakic patients is a known complication after vitrectomy. A previous study found that especially patients receiving gas tamponade are at increased risk for postoperative cataract development. The assumed mechanism behind this finding is that vitrectomy leads to an increased partial pressure of O2 in the human vitreous - similar to that observed in posterior vitreous detachment - subsequently leading to accelerated lens opacification. Therefore, a possible target of cataract prevention is the inhibition of oxygen radical formation. One known antioxidant agent inhibiting oxygen radical formation is caffeine. For instance, in-vitro studies showed that caffeine consumption can reduce cataract development in ultraviolet (UV)-radiation-exposed rats and human lens epithelial cells through its capability of inhibiting oxygen radical formation. These in-vitro studies support the findings of epidemiological studies that caffeine also in-vivo has the potential to reduce cataractogenesis. Conflating the previous findings of accelerated cataract formation after vitrectomy and the preventive properties of caffeine for cataract development, there may be a benefit for patients regularly consuming caffeine-containing beverages like coffee undergoing vitrectomy regarding postoperative cataract formation.

Therefore, the aim of this comparative study is to investigate if patients undergoing small gauge pars plana vitrectomy regularly consuming caffeine have lower postoperative significant cataract formation rates than patients not consuming caffeine.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andreas Schlatter, MD; Phone Number: 57564 +4391021; Email: office@viros.at
• Study Contact Backup: Name: Christoph Leisser, DDr.; Phone Number: 57564 +4391021; Email: office@viros.at

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Recruiting
    • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna
    • Contact: Andreas Schlatter, MD; Phone Number: 57564 +4391021; Email: office@viros.at
    • Contact: Christoph Leisser, MMD; Phone Number: 57564 +4391021; Email: office@viros.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 or older
• Written informed consent
• No previous cataract surgery in the study eye
• Scheduled small gauge vitrectomy with intraoperative gas tamponade (SF6 or C3F8) due to retinal detachment or macular hole repair
• No regular caffeine consumption (drinking not more than one cup of a caffeine- containing beverage [e.g. coffee, energy drinks] at a maximum of two days per week during the past year)

Exclusion Criteria:

• Intake of systemic or topical corticosteroids within 3 months before study screening
• Increased risk for postoperative cataract development, for example due to ocular trauma in the history
• Severe cataract (LOCS III grading of any cataract form >2) in the study eye at pre- study screening
• Scheduled phacovitrectomy in the study eye
• Participation in any clinical trial three month before study screening
• Ocular surgeries six month before study screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caffeine consumption; Patients with regular caffeine consumption needing pars plana vitrectomy	Procedure: Pars plana vitrectomy; Standard pars plana vitrectomy will be performed
Experimental: No caffeine consumption; Patients with regular caffeine consumption needing pars plana vitrectomy	Procedure: Pars plana vitrectomy; Standard pars plana vitrectomy will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Significant cataract formation at year 1	Frequency of significant cataract formation one year after vitrectomy in study eyes as compared to control eyes	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Significant cataract formation at month 6	Frequency of significant cataract formation 6 months after vitrectomy in study eyes as compared to control eyes	12 months
Distance corrected visual acuity (DCVA)	DCVA at all study visits in study eyes as compared to control eyes	12 months

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery
• Investigators: Principal Investigator: Oliver Findl, Prim. Dr., Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Krankenhaus

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Caffeine; Retinal detachment; Pars plana vitrectomy; Macular Pucker
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Caffeine Vitrectomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No